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About the US Early Access Program

The US Amylyx Early Access Program will provide access to our investigational product AMX0035 (also known as PB & TURSO) for people with amyotrophic lateral sclerosis (ALS) who might not be able to take part in our clinical trial(s).

What is AMX0035?

AMX0035 is the investigational product used in the US Early Access Program. It is a combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO). AMX0035 is a powder for oral suspension that should be mixed with room temperature water and drank or given through a feeding tube.

Who can participate in the US Early Access Program?

Select Eligibility Criteria*

  • Certain adults with ALS, 18 years and older

  • Diagnosis of ALS made by doctor with experience managing people with ALS

  • 3+ years (36 months) of ALS symptoms (first symptom noticed at least 3 years ago)

  • Not eligible for a clinical trial

 

*Additional criteria apply

If you're interested, talk to your doctor about if the US Early Access Program is right for you.

If you meet the criteria above, you may be eligible for the US Early Access Program. There are additional criteria. If you're interested in participating, talk to your ALS doctor or care team to find out if this program is right for you. For a full list of criteria, please visit www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05286372).